510(k) K090885

NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER by Nephros, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2009
Date Received
March 31, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type